Giraffe OmniBed Field Replaceable Unit (FRU): recall status

Notice names this product. GE Medical Systems’s Giraffe OmniBed Field Replaceable Unit (FRU) is named in FDA Class II recall Z-2477-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury. Identifying details: Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382. Units affected: 265 units. Status: Ongoing.